Package Insert: Information for the User

PENTASA 500 milligrams prolonged-release tablets

Mesalazine

Read this package insert carefully before you start taking your medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isPentasa tabletsand what is it used for

2. What you need to know before you start takingPentasa tablets

3. How to takePentasa tablets

4. Possible side effects

5. Storage ofPentasa tablets

6. Contents of the pack and additional information

Pentasa tablets is indicated to help you remain free of new flare-ups of ulcerative colitis.

Ulcerative colitis is an inflammatory bowel disease in which the lining of the intestine is inflamed and develops many small breaks in its surface (ulcers) that can bleed.

Pentasa contains the active ingredient mesalazine, which belongs to a group of medicines called anti-inflammatory intestinal agents that help reduce inflammation and painful symptoms.

Do not take Pentasa tablets:

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).

• if you are allergic to salicylates, for example aspirin.

• if you have severe kidney and/or liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pentasa tablets:

• if you are allergic to sulfasalazine (risk of salicylate allergy).

• if you currently have or have had previously impaired liver or kidney function.
• if you have a disease that may make you prone to bleeding.

• if you are taking a treatment that may affect kidney function, for example non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin.
• if you have respiratory problems, particularly asthma.

• interrupt treatment immediately in case of cramps, abdominal pain, fever, severe headache, and rash.
• Renal calculi may occur with the use of mesalazine. Symptoms include abdominal pain on one side and blood in the urine. Ensure you drink a sufficient amount of liquid during treatment with mesalazine.
• If you have ever experienced a severe skin rash or skin peeling, blisters, or mouth sores after using mesalazine.

Mesalazine may cause urine discoloration to a reddish-brown color after contact with sodium hypochlorite bleach in toilet water. This is a chemical reaction between mesalazine and bleach and is harmless.

Be especially careful with mesalazine:

Severe skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN), have been observed with mesalazine treatment. Stop taking mesalazine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you experience severe or recurring headaches, vision changes, or ringing or buzzing in your ears, contact your doctor immediately.

While on treatment with this medicine, your doctor will perform blood and urine tests to monitor your kidney function, especially at the start of treatment.

Use in patients over 65 years:

Use with caution in patients over 65 years and only in patients with normal kidney function.

Children and adolescents:

There is limited documentation on the effect in children (6-18 years). Dosage will be determined by your doctor.

Use of Pentasa tablets with other medicines:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is especially important if you are taking any of the following medicines:

• azathioprine (used after transplants or to treat autoimmune diseases)

• 6-mercaptopurine or thioguanine (chemotherapy, used to treat leukemia)
• certain blood-thinning medications (medicines for thrombosis or to thin your blood).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited experience with the use of mesalazine during pregnancy and breastfeeding.

Blood disorders have been observed in newborns of mothers treated with this medicine. Newborns may develop allergic reactions after breastfeeding, for example, diarrhea. If the newborn experiences diarrhea, breastfeeding should be stopped.

Fertility:

Mesalazine data in animals show that it has no effect on male or female fertility.

Driving and operating machinery:

The treatment with Pentasa tablets does not appear to have any influence on the ability to drive and/or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

To help you stay free of more flare-ups of colitis, your doctor may prescribe you generally 2 grams of mesalazine per day, administered in the form of 4 tablets once a day.

Use in children and adolescents (6 years of age or older):

The dose will be calculated by your doctor based on your body weight. The recommended dose in children and adolescents with a body weight of up to 40 kg will be half the usual recommended dose in adults, and for those children and adolescents with a body weight greater than 40 kg, the dose will be the same usual recommended dose in adults.

You must take the tablets whole orally(by mouth). To facilitate administration, they can be suspended in water or orange juice, shaken, and ingested immediately.

If you estimate that the action of this medication is too strong or too weak, inform your doctor.

If you take more Pentasa tablets than you should

No cases of overdose have been reported in humans, but if you suspect an overdose, you must immediately consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Pentasa tablets:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pentasa tablets

Your doctor will indicate the duration of your treatment with Pentasa tablets. Do not discontinue treatment before finishing it, even if you feel better, as symptoms may return if you stop treatment too soon. Follow your doctor's treatment instructions strictly in the maintenance period established.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Pentasa tabletsmay cause side effects, although not everyone will experience them.

Severe side effects:

Few cases of severe allergic reaction (including severe skin erosions that can affect the skin as a body barrier) have been reported. The allergic reaction could lead to swelling of the face and neck and/or difficulty breathing or swallowing (Quincke's edema). If this occurs, contact your doctor or emergency services immediately.

Inform your doctor immediately if you experience severe headache or recurrent, vision changes or ringing or buzzing in your ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

Stop taking mesalazine and seek medical help immediately if you experience any of the following symptoms:

• flat red patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, generalized rash, fever, and lymph node enlargement. These severe skin eruptions are often preceded by fever or flu-like symptoms.

The following frequent side effectsaffect between 1 and 10 of every 100 patients treated:

• headache
• diarrhea
• nausea
• abdominal pain
• vomiting
• skin rash
• flatulence (gas)

The following rare side effects,affect between 1 and 10 of every 10,000 patients treated:

• inflammation of some areas of the heart (myocarditis and pericarditis) that can cause difficulty breathing and chest pain or palpitations (rapid or irregular heartbeats)
• pancreatitis (including symptoms of back and/or stomach pain) and increased amylase
• dizziness
• increased skin sensitivity to sunlight and ultraviolet light (photosensitivity)

The following very rare side effects,affect fewer than 1 of every 10,000 patients treated:

• eosinophilia (as part of an allergic reaction) and blood disorders such as reduced red blood cells (anemia), white blood cells (leucopenia), and platelets (thrombocytopenia), which can increase the risk of infections or bleeding.
• liver disorders (hepatitis) characterized by symptoms that include jaundice (yellowing of the skin and/or eyes) and/or pale stools.
• kidney disorders(symptoms include blood in the urine, swelling due to increased fluid, and/or increased blood pressure (nephritis))
• peripheral neuropathy (condition affecting the nerves of the hands and feet, including symptoms of tingling and numbness)
• allergic and fibrotic lung reactions (symptoms include cough, difficulty breathing, bronchospasm, bloody or excessive sputum)
• hair loss (this is reversible)
• muscle or joint pain
• inflammation that can affect various parts of the body, such as joints, skin, kidneys, heart, etc. (symptoms include painful joints, fatigue, fever, abnormal bleeding or bruising, contusion, skin discoloration, and/or subcutaneous nodules)
• semen with low sperm concentration (oligospermia) (this is reversible)
• severe diarrhea and abdominal pain due to an allergic reaction to this medication in the intestine
• occasionally, allergic reactions and fever may occur

Unknown frequency(cannot be estimated from available data)

• kidney stones and associated renal pain (see also section 2)
• change in urine color
• If you experience severe headache or recurrent, vision changes or ringing or buzzing in your ears. These could be symptoms of increased pressure inside your skull (idiopathic intracranial hypertension).

Some of these adverse reactions may also be attributed to the underlying disease itself.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofPentasa tablets

- The active ingredient is mesalazine. Each tablet contains 500 milligrams of mesalazine.

- The other components are: Povidone, microcrystalline cellulose, magnesium stearate, talc, ethylcellulose.

Appearance of the product and contents of the packaging

Pentasa tablets are presented as greyish/brown pale, round, speckled, marked, and engraved tablets: 500 mg on one side, PENTASA on the other side.

They are presented in a double aluminum blister of 50 or 100 tablets.

Pentasa tablets may only be marketed in some package sizes.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Ferring S.A.U

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Responsible manufacturer:

FERRING GmbH

Wittland 11

24109 Kiel, Germany

Last review date of this leaflet in January 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/